Venetoclax to Augment Epigenetic Modification and Chemotherapy

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT05317403
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia Refractory
  • Acute Myeloid Leukemia, in Relapse

Eligibility Criteria

Sex
ALL
Age
1 Year - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Dose Level 0: Day 1 60 mg/m2 PO x1, Days 2-14 120 mg/m2/dose PO once daily (Max: 200 mg/day) Dose level 1: Day 1 120 mg/m2 PO x1, Days 2-14 240 mg/m2/dose PO once daily (Max: 400 mg/day) Dose level 2: Day 1 180 mg/m2 PO x1, Days 2-14 360 mg/m2/dose PO once daily (Max: 600 mg/day)
  • Azacitadine — DRUG
    75 mg/m2/dose IV once daily over 15 minutes
  • Vorinostat — DRUG
    1 year to 17.99 years old: 180 mg/m2/dose PO once daily ≥18 years old 200 mg PO BID. Doses should be separated by 12 hr (±4 hr)
  • Cytarabine — DRUG
    2000 mg/m2/dose IV once daily over 3 hours IT Cytarabine: 1. \- 1.99 years old: 30 mg 2. \- 2.99 years old: 50 mg * 3 years old: 70 mg
  • Fludarabine — DRUG
    30 mg/m2/dose IV once daily over 30 minutes
  • Filgrastim — DRUG
    5 microgram/kg/dose subcutaneous (or IV over 15-30 min) once daily

Study Details

The investigator is testing the addition of venetoclax to 5-azacitidine and vorinostat followed by standard chemotherapy to enhance treatment response in AML patients.

Key Dates

Start date
Mar 31, 2023
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: AML without Down Syndrome
    The subject receives 2 courses of therapy approximately 35 days each. Venetoclax: Days 1-14 Azacitidine and Vorinostat: Days 1-5 Filgrastim Days: 5 start and continue until post-nadir ANC \> 500 cells/mm3 Fludarabine and Cytarabine Days 6 - 10 IT Cytarabine Day 0 or 1, optional between day 35 and 42
  • Other: AML with Down Syndrome
    The subject receives 2 courses of therapy approximately 35 days each. Venetoclax: Days 1-14 Azacitidine and Vorinostat: Days 1-5 Filgrastim Days: 5 start and continue until post-nadir ANC \> 500 cells/mm3 Fludarabine and Cytarabine Days 6 - 10 IT Cytarabine Day 0 or 1, optional between day 35 and 42

Primary Outcome Measure

Venetoclax Dose-Limiting Toxicity [ Time Frame: 42 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's WisconsinMilwaukeeWisconsin53226
Amberley Kemic, RN
[email protected]
414-266-2038
[email protected]
Michael Burke, MD (PRINCIPAL_INVESTIGATOR)
Zachary T. Graff, MD (SUB_INVESTIGATOR)

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